Corporate QA Compliance Specialist - Saluggia, Italy - ITA 2021-021

Job Title

Corporate QA Compliance Specialist

Job Facts

Organizational Area
Corporate
Country / State
Italy
Place of work
Saluggia
Home/Office based
Office based

Professional Family: 

  • Quality
Reporting To
Corporate Compliance & Quality System Senior Manager

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Permanent
Job ID
ITA 2021-021

Job Scope

Your Mission

The mission of Corporate QA Compliance Specialist is to ensure that all the compliance activities are effectively and efficiently organized, planned and delivered with particular attention to the requirements of FDA QSR 21CFR Part 820, IVD-MD 98/79/EC Directive, IVD REGULATION (EU) 2017/746, ISO 13485 (including MDSAP approach) and ISO 9001

Main Responsibilities

Your Contributions

The Corporate QA Compliance Specialist works individually or as part of the team, responsible at Corporate level for:

a) conducting Internal Quality audits, in order to verify that all the QS requirements and procedures are correctly implemented and respected within the DiaSorin Group (he/she may audit departments, systems, products, processes, documents) and monitoring the CAPA Plans, if any.

b) conducting Quality audits at Corporate Suppliers and monitoring the CAPA Plans, if any.

c) Monitoring the effective compliance of the DiaSorin sites and affiliates to the applicable FDA, ISO, IVD MD Directive and Regulation 2017/476 requirements, also through the review of technical documents.

d) Supporting DS sites concerning Validation Activities, readiness of inspection programs, GMP requirements implementation

e) Acting as independent reviewer in design or changes HW and SW activities to ensure compliance of project documentation, guaranteeing the adequateness and the fulfillment of Analyzers HW&SW projects.

f) providing technical support for Regulatory assessments related to IVD MD Directive and Regulation 2017/476 about analyzers.

Qualifications Experience Personal Strengths Mobility

You
Education
Bachelor’s Degree
Specialization
or a professional qualification of an equivalent or higher standard, preferably in LyfeScience and technical.
Experience

A minimum of 2-3 years’ work experience in a quality or regulatory role in the pharmaceutical, healthcare or medical device/IVD sector essential, preferably in an FDA regulated environment

Technical Competencies

Knowledge of relevant IVD medical device technologies and related design and manufacturing processes, knowledge of Quality Management System and current International and European regulations/standards to respect to IVD MD.

Skills
  • Personal characteristics: integrity, ethics, confidentiality, sincerity, diplomacy, open-mind, sense of observation, perspicacious, persevering, resolute, self-confident.

  • Abilities: excellent attention to detail and organization skills, ability to work equally as well on your own as in a team, excellent interpersonal skills, be organized and flexible, excellent written and verbal communication skills, ability to work under pressure and meet tight deadlines, good problem solving and decision making.

  • Computer skills: seasoned experience using Microsoft Excel, Word, PowerPoint.

Languages
Fluent spoken and written English. Fluency in second European Language is a plus
Travel Availability
Available to travel within Europe Countries, to USA, Asia and where needed for business purposes
Relocation Availability
No
Training Required

Induction Program once hired

Benefits

We Offer You

As for Company Policy